infertility patients with normal ovarian response to assisted reproduction
Conditions
Interventions
dual trigger group:250ug rHCG+0.2mg triprorelin
HCG group:250ug rHCG
Sponsors
The Third Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Female, married, and infertile, aged =20 years and <40 years, with indications for IVF-ET or ICSI. 2. Body Mass Index (BMI) between 18 and 28 kg/m² (excluding boundary values). 3. Regular menstrual cycles (24-35 days, including boundary values) in the last 3 months prior to screening. 4. Normal expected ovarian response, fulfilling the following criteria: (1).Serum hormone panel (including Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Progesterone (P), Prolactin (PRL), Testosterone (T)) on days 2-4 of the menstrual cycle: FSH = 10IU/L (or 10mIU/mL); LH, E2, P, PRL, T within normal laboratory ranges or considered clinically insignificant abnormalities by the investigator. (2) Anti-Müllerian Hormone (AMH) levels: 1.2 ng/mL (8.57 pmol/l) = AMH = 4.5 ng/mL (32.13 pmol/l). (3) Antral Follicle Count (AFC) on days 2-4 of the menstrual cycle via ultrasound: 7-24 follicles measuring 2-9 mm in diameter in both ovaries. 5. Subjects and their spouses voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Undergone 3 or more COH cycles of IVF/ICSI-ET without achieving clinical pregnancy. 2. Previous IVF or ICSI cycles with fertilization failure due to poor sperm quality/fertilization issues, and the relevant medical condition has not improved. 3. History of =2 spontaneous abortions or embryonic arrests. 4. High risk of ovarian hyperstimulation syndrome (OHSS) as determined by the Golan classification (e.g., moderate-to-severe OHSS during previous COH cycles, polycystic ovarian syndrome (PCOS) as per the 2018 Chinese PCOS guidelines, OHSS or OHSS risk leading to cycle cancellation). 5. Impaired ovarian function with at least one of the following: poor ovarian response in previous cycles (=3 oocytes retrieved with standard full-dose gonadotropin (Gn) stimulation protocols); bilateral ovarian AFC 4 cm or 3.5 cm, simple ovarian cysts > 5 cm, inability to retrieve oocytes from one or both ovaries, hydrosalpinx affecting pregnancy as assessed by the investigator. (3) Stage III-IV endometriosis or adenomyosis confirmed by previous surgery or diagnosis according to the American Society for Reproductive Medicine (ASRM) criteria. 7. Couples with immune dysfunction or chromosomal abnormalities. 8. Uncorrected endocrine disorders (e.g., thyroid dysfunction, abnormal blood glucose levels).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ongoing pregnancy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of oocytes;Number of 2PN fertilized eggs and 2PN fertilization rate;Number and rate of high-quality embryos;Serum beta-hCG/hCG positive rate;Clinical pregnancy rate;Embryo implantation rate; | — |
Countries
China
Contacts
Public ContactWenxia Liu
The Third Affiliated Hospital of Zhengzhou University
Outcome results
None listed